Clause 5 - Abbreviated Advertisements
5.1 Abbreviated advertisements are advertisements which are exempt from the requirement to include prescribing information for the advertised medicine, provided that they meet with the requirements of this clause.
5.2 Abbreviated advertisements may only appear in professional publications ie publications sent or delivered wholly or mainly to members of the health professions and/or other relevant decision makers. A loose insert in such a publication cannot be an abbreviated advertisement.
Abbreviated advertisements may contain only the information specified in Clauses 5.4, 5.5, 5.6, 5.7 and 5.8.
Abbreviated advertisements are not permitted in audio-visual material or in interactive data systems or on the Internet, including journals on the Internet.
Clause 5.2 Professional Publications
Abbreviated advertisements are largely restricted to journals and other such professional publications sent or delivered wholly or mainly to members of the health professions etc. A promotional mailing or representative leavepiece cannot be an abbreviated advertisement and an abbreviated advertisement cannot appear as part of another promotional item, such as in a brochure consisting of a full advertisement for another of the company's medicines.
DVDs and suchlike sent to doctors etc may be considered professional publications and an abbreviated advertisement may be included on a box containing a DVD. The prescribing information must, however, be made available for any advertisement for a medicine appearing on audio-visual material or in an interactive data system or on the Internet, including online journals. Such advertisements cannot be deemed abbreviated advertisements.
5.3 Abbreviated advertisements must be no larger than 420 square centimetres in size.
5.4 Abbreviated advertisements must provide the following information in a clear and legible manner:
- the name of the medicine (which may be either a brand name or a non-proprietary name)
- the non-proprietary name of the medicine or a list of the active ingredients using approved names where such exist
- at least one indication for use consistent with the summary of product characteristics
- the legal classification of the product
- any warning issued by the Medicines Commission, the Commission on Human Medicines, the Committee on Safety of Medicines or the licensing authority which is required to be included in advertisements
- the name and address of the holder of the marketing authorization or the name and address of the part of the business responsible for its sale or supply
- abbreviated advertisements must include the statement ‘Information about this product, including adverse reactions, precautions, contra-indications and method of use can be found at [the address of the website referred to below] ‘and state that prescribers are recommended to consult the summary of product characteristics before prescribing.
The following information must be provided on the website referred to above:
either, the information set out in Clauses 4.2 and 4.3 (except that the non-proprietary name of the medicine or the list of active ingredients, as required by Clause 4.3, must appear immediately adjacent to the most prominent display of the brand name in a size such that the information is readily readable and information about cost as required by Clause 4.2 need not be included on the website where the abbreviated advertisement appears only in journals printed in the UK which have more than 15 per cent of their circulation outside the UK),
or, the summary of product characteristics.
Clauses 5.4, 5.5, 5.6, 5.7, 5.8 and 5.9 Abbreviated Advertisements – Permitted Information
The contents of abbreviated advertisements are restricted as set out in Clauses 5.4, 5.5, 5.6, 5.7, 5.8 and 5.9 and the following information should not therefore be included in abbreviated advertisements:
- dosage particulars
- details of pack sizes
There may be exceptions to the above if the information provided, for example the cost of the medicine or the frequency of its dosage or its availability as a patient pack, is given as the reason why the medicine is recommended for the indication or indications referred to in the advertisement.
Artwork used in abbreviated advertisements must not convey any information about a medicine which is additional to that permitted under Clauses 5.4, 5.5, 5.6, 5.7, 5.8 and 5.9.
Telephone numbers may be included in abbreviated advertisements.
5.5 In addition, the non-proprietary name of the medicine or a list of the active ingredients using approved names where such exist must appear immediately adjacent to the most prominent display of the brand name in bold type of a size such that a lower case ‘x’ is no less than 2mm in height or in type of such a size that the non- proprietary name or list of active ingredients occupies a total area no less than that taken up by the brand name.
5.6 In addition, abbreviated advertisements must include the prominent statement ‘Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to [relevant pharmaceutical company]’.
Clause 5.6 Adverse Event Reporting
A telephone number or email address for the relevant department of the company may be included.
In the event that the website address given in Clause 5.6 is changed by the Medicines and Healthcare Products Regulatory Agency, companies may use a statement incorporating the new address as soon as the change is made and must use the new address within one year of the change.
5.7 When required by the licensing authority, abbreviated advertisements must show an inverted black equilateral triangle to denote that additional monitoring is required in relation to adverse reactions.
Clause 5.7 Black Triangle Symbol
The agreement between the then Committee on Safety of Medicines and the ABPI on the use of the black triangle is that:
The symbol should always be black and its size should normally be not less than 5mm per side but with a smaller size of 3mm per side for A5 size advertisements and a larger size of 7.5mm per side for A3 size advertisements:
- the symbol should appear once and be located adjacent to the most prominent display of the name of the product
- no written explanation of the symbol is necessary.
It should be borne in mind that abbreviated advertisements must be no larger than 420 square centimetres in size. In abbreviated advertisements of no more than 310.8 square centimetres (A5) each side should be no less than 3mm. In abbreviated advertisements larger than A5 (but no larger than 420 square centimetres) each side should be no less than 5mm.
5.8 Abbreviated advertisements may in addition contain a concise statement consistent with the summary of product characteristics, giving the reason why the medicine is recommended for the indication or indications given.
5.9 Marketing authorization numbers and references must not be included in abbreviated advertisements.